A U.S. Food and Drug Administration (FDA) advisory panel concluded that prescription pain medication celecoxib (Celebrex), marketed by Pfizer, is as safe as other common nonsteroidal anti-inflammatory drugs (NSAIDs) when it comes to cardiovascular (CV) risks. The panel recommended updating the medicine’s safety labeling to reflect that.
Celecoxib is a selective COX-2 inhibitor, which means it blocks production of an enzyme associated with inflammation. “Nonselective” NSAIDs, such as naproxen and ibuprofen, block both COX-1 and COX-2; by blocking COX-1, they give rise to gastrointestinal (GI) side effects. Celecoxib is often prescribed to patients with osteoarthritis (OA) or an inflammatory type of arthritis, such as rheumatoid arthritis (RA), especially those who are at higher risk of GI side effects.
But its cardiovascular safety profile has been under a cloud of suspicion for more than a decade, after two other COX-2 inhibitors were pulled from the U.S. market. Rofecoxib (Vioxx) was removed in 2004 and valdecoxib (Bextra) in 2005 over concerns they raised the risk of cardiovascular events, such as heart attack and stroke, to unacceptable levels. (All NSAIDs increase the risk of cardiovascular side effects; risks rise with the dose and length of time used.)
Continue reading FDA Advisory Panel Recommends Softening “Celebrex” Safety Labeling
The United States has been grappling with a growing opioid epidemic that is forcing doctors, policymakers and patients to come up with alternative ways to manage both chronic and acute pain and reduce the amount of opioid prescribing in the country. A pair of studies presented recently at the 2018 meeting of the American Association of Orthopaedic Surgeons (AAOS) in New Orleans examine two possibilities for patients undergoing surgery.
The first study found that counseling before surgery significantly cuts the number of opioids patients take after hand surgery. And the second study, led by the same doctor, showed that ibuprofen and acetaminophen each treats postsurgical pain from hand surgery as well as oxycodone.
Continue reading Two Studies Highlight Opioid Alternatives
Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot of Synvisc-One, a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.
Continue reading Synvisc-One Injections Recalled
A big study published in 2016, called the PRECISION trial, found that people with arthritis who take the anti-inflammatory drug ibuprofen are more likely to develop cardiovascular problems than those using celecoxib – and now researchers think they know why. Ibuprofen raises blood pressure, according to new findings presented recently at the annual meeting of the European Society of Cardiology in Barcelona.
Continue reading Ibuprofen May Raise Heart Risk More Than Other NSAIDs
The number of biosimilars approved by the Food and Drug Administration (FDA) continues to grow in the United States, and they are slowly becoming available to consumers.
In late August, the FDA approved Cyltezo (adalimumab-adbm), a second biosimilar to Humira (adalimumab). But like the first biosimilar, Amjevita (adalimumab-atto), which was approved in September 2016, it is not yet available to U.S. consumers because of pending patent litigation with AbbVie, the manufacturer of Humira.
Continue reading FDA Approves A Fifth Biosimilar for Arthritis, But Three Are Still Not Available
If you’ve been diagnosed with mild to moderate fibromyalgia, exercise and other non-drug therapies should be your first line of treatment, according to the European League Against Rheumatism (EULAR), an international group of health professionals in rheumatology. EULAR’s updated fibromyalgia treatment recommendations, published in 2016 in Annals of the Rheumatic Diseases, are similar to the 2007 version, but this time they are based on hard evidence, which was scarce 10 years ago, rather than on expert opinions.
For the updated guidelines, researchers reviewed 107 research papers. Assessing outcomes for pain, fatigue, sleep and daily functioning, they ranked their recommendations of various therapies as “strong for,” “weak for,” “weak against” and “strong against.”
Continue reading Top Fibro Treatments
At the request of the U.S. Food and Drug Administration (FDA), Endo Pharmaceuticals has removed from the market its long-acting opioid pain medication, Opana ER (oxymorphone hydrochloride extended release), which some patients with arthritis take to manage chronic pain.
Continue reading At FDA Urging, Drug Maker Pulls Opana ER Off Market